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Volume-Stable Collagen Matrix vs. Connective Tissue Graft for Peri-Implant Soft Tissue Defects

NCT07782125 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-08-24

No results posted yet for this study

Summary

Peri-implant soft-tissue defects will be treated with either a volume-stable collagen matrix (VCMX; test group) or an autogenous connective tissue graft (CTG; control group) following implant placement in patients with a single missing tooth. After a mid-crestal incision and full-thickness flap elevation, the graft material will be positioned over the crest beneath the buccal flap and stabilized, followed by tension-free primary closure. Peri-implant soft-tissue thickness, echo intensity, and vascularization will be assessed non-invasively using high-resolution intraoral ultrasonography and Power Doppler imaging. Clinical periodontal parameters and patient-reported outcomes, including pain perception (visual analog scale), swelling, fatigue, analgesic consumption, and wound healing, will be recorded. These outcomes will be evaluated at baseline and on the 1st week, 1st, 3rd, and 6th months. At the 6th month, gingival biopsy samples obtained during healing abutment placement will be evaluated histologically and immunohistochemically (CD11c, CD163, COL1, COL3, MMP-1, TIMP-1) to compare the biological integration of the two graft materials.

Conditions

  • Dental Implantation
  • Peri-Implant Soft Tissue Deficiency
  • Soft Tissue Augmentation

Interventions

PROCEDURE

Connective tissue graft

An autogenous connective tissue graft harvested from the palate using the extraoral de-epithelialization technique will be placed over the crest beneath the buccal flap and stabilized with simple interrupted sutures (6-0 polypropylene) to augment peri-implant soft-tissue thickness. (control group)

DEVICE

Volume-stable collagen matrix

A volume-stable porcine-derived collagen matrix (15×20×3 mm) will be trimmed to the defect size, placed over the crest beneath the buccal flap, and stabilized with simple interrupted sutures (6-0 polypropylene) to augment peri-implant soft-tissue thickness. (test group)

Sponsors & Collaborators

  • Ankara University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-18
Primary Completion
2026-09-01
Completion
2026-09-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07782125 on ClinicalTrials.gov